U.S. patent number 5,112,306 [Application Number 07/457,423] was granted by the patent office on 1992-05-12 for method and apparatus for valving body fluids.
This patent grant is currently assigned to American Medical Systems, Inc.. Invention is credited to Eric P. Berg, John H. Burton, Frank B. Scott, Bradford G. Staehle.
United States Patent |
5,112,306 |
Burton , et al. |
May 12, 1992 |
Method and apparatus for valving body fluids
Abstract
A method and apparatus for valving body fluids involving a
flexible tubular body with a drainage canal therethrough, including
collapsible means for blocking the passageway and thereby
preventing the flow of urine. The length of the device is such that
one end protrudes into the bladder and the other end terminates
interior of the meatus. The device includes a means for anchoring
to secure it in place and a plug device for deflating and releasing
the anchoring means and for collapsing the blocking means to
facilitate removal of the device from the body. The device is
manually actuable to an open position and means are provided to
delay the closing of the device for a sufficient period of time to
allow voiding of the bladder. The collapsible and expandable nature
of the device facilitates its insertion and removal, particularly
while passing through areas of restricted diameter.
Inventors: |
Burton; John H. (Minnetonka,
MN), Berg; Eric P. (Woodbury, MN), Staehle; Bradford
G. (Minnetonka, MN), Scott; Frank B. (Houston, TX) |
Assignee: |
American Medical Systems, Inc.
(Minnetonka, MN)
|
Family
ID: |
27038591 |
Appl.
No.: |
07/457,423 |
Filed: |
December 27, 1989 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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267748 |
Nov 2, 1988 |
4909785 |
|
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843747 |
Mar 25, 1986 |
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Current U.S.
Class: |
604/101.02;
128/DIG.25; 600/29; 604/101.05; 604/247; 604/919 |
Current CPC
Class: |
A61F
2/0027 (20130101); A61M 25/1011 (20130101); A61M
25/0075 (20130101); Y10S 128/25 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61M 25/00 (20060101); A61M
25/10 (20060101); A61M 029/00 () |
Field of
Search: |
;604/54,96,101,246,247,280 ;600/29-31 ;128/DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pellegrino; Stephen C.
Assistant Examiner: Lewis; Ralph A.
Attorney, Agent or Firm: Richardson; Peter C. Akers;
Lawrence C. Dryer; Mark
Parent Case Text
This is a continuation of application Ser. No. 267,748, filed on
Nov. 2, 1988, now U.S. Pat. No. 4,909,785 which is a continuation
of U.S. Pat. No. 843,747 filed on Mar. 25, 1986, now abandoned.
Claims
What is claimed is:
1. An indwelling valving device, comprising:
a flexible tubular body having distal and proximal ends and
defining a longitudinal passageway therethrough;
anchoring means for securing said body in place; and
collapsible blocking means for blocking said passageway, said
blocking means operable to collapse by manual pressure to allow
fluid flow through said passageway and operable to expand by
gradual pressure equalization to again block said passageway when
the desired fluid flow is completed.
2. An indwelling valving device of claim 1, further comprising
releasing means operable to release said anchoring means and enable
said device to be removed from the urethra.
3. An indwelling valving device of claim 1, further comprising
pressure equalizing bleed-back means for delayed closing of said
blocking means after said blocking means has been actuated to an
unblocking position.
4. An indwelling valving device of claim 1 wherein said anchoring
means further comprises first and second anchoring means.
5. An indwelling valving device of claim 4 wherein said first
anchoring means secures said tubular body adjacent the bladder and
said second anchoring means anchors said tubular body adjacent the
proximal urethra.
6. An indwelling valving device of claim 4 wherein said first and
second anchoring means comprise inflatable members.
7. An indwelling valving device of claim 6, further comprising
valve means for inflating said inflatable members from said distal
end.
8. An indwelling urinary continence device, comprising:
a flexible tubular body having distal and proximal ends and having
a first passageway extending longitudinally therethrough;
a first fixation means secured to the exterior surface of said
proximal end of said body;
a second fixation means secured to the exterior surface of said
body; and
an inflatable member secured within said first passageway, said
inflatable member inflatable to close said first passageway and
manually compressible to open said first passageway.
9. An indwelling urinary continence device as in claim 8, wherein
said first fixation means is inflatable.
10. An indwelling urinary continence device as in claim 9, further
comprising:
a second passageway extending from the interior of said inflatable
member to the interior of said first fixation means; and
differential pressure flow controller means in said second
passageway enabling rapid balancing of pressures between said first
fixation means and said inflatable member when the pressure in said
inflatable member exceeds the pressure in said first fixation
means, and enabling a time-delayed balancing of pressures when the
pressure in the first fixation means exceeds the pressure in the
inflatable member.
11. An indwelling urinary continence device comprising:
a tubular body adapted to be inserted in the urethra with one end
extending into the bladder and the opposite end spaced inwardly of
the meatus, said tubular body having upper and lower portions and
said lower portion defining an annular space when positioned within
the urethra;
a first inflatable member secured to the exterior surface of said
upper portion of said tubular body and positioned to be within the
bladder upon inflation;
a second inflatable member secured to the exterior surface of said
upper portion of said tubular body and positioned to engage the
urethra upon inflation;
a third inflatable member secured to the exterior surface of said
lower portion of said tubular body; and
a first passageway in said tubular body to drain said bladder into
said annular space between the urethra and said lower portion of
said tubular body.
12. The indwelling urinary continence device of claim 11, further
comprising:
a second passageway in said tubular body extending from the
interior of said third inflatable member to said first inflatable
member; and
differential pressure flow controller means in said second
passageway for enabling rapid balancing of pressures between said
first and third inflatable members when the pressure in said third
inflatable member exceeds the pressure in said first inflatable
member, said controller means including means for enabling a
time-delayed balancing of pressures when the pressure in said first
inflatable member exceeds the pressure in said third inflatable
member.
13. The device of claim 11 including a collapsible sheath attached
along its upper periphery to the periphery of the lower end of said
upper portion of said tubular body, said sheath surrounding said
third inflatable member so as to be collapsible upon insertion of
said device but expandable to full diameter when properly
positioned.
14. The device of claim 11 including:
a valve chamber in the lower end of said tubular body vented to
provide fluid communication between said valve chamber and each
said inflatable member, and between said valve chamber and said
urethra; and
a valve member operable in said valve chamber between a first
position in which said vents are all open and a second position in
which all said vents are closed.
15. The device of claim 11 in which said inflatable members are
balloons.
16. The device of claim 11 in which said third inflatable member is
positioned to be adjacent the perineum so as to be easily
compressible from the exterior surface of the body.
17. An indwelling urethral device comprising:
a tubular body adapted to be inserted into the urethra and extend
from an upper end in communication with the bladder to a lower end
spaced above the lower end of the urethra;
a first balloon at the upper end of said tubular body inflatable
from the lower end of said tubular body to expand into an anchoring
position within the bladder;
a second balloon at and inflatable from the lower end of said
tubular body to seal against the wall of the urethra;
a first lumen in said tubular body communicating between said
balloons;
flow control means in said first lumen operable to promptly relieve
differential pressures above a preselected value from said second
balloon to said first balloon; and
time delay means for the gradual release of said differential
pressures from said first balloon to said second balloon.
18. The device of claim 17, including:
an anchor on said tubular body between said balloons pneumatically
actuable from said lower end of said tubular body to anchor said
device within said urethra.
19. The device of claim 17, including:
a second lumen in said tubular body adapted to drain the bladder
into the urethra above said second balloon.
20. The device of claim 19, including:
a valve chamber in the lower end of said tubular body vented to
communicate with said balloons and said anchor for the passage of
fluid therebetween; and
a valve operable in said chamber between a first position opening
such vents and a second position closing such vents.
21. An indwelling valving device for use in a body passageway
comprising:
an elongated member defining a first longitudinal passageway and
adapted to be inserted into said body passageway, said member
defining an annulus with the body passageway;
a first expansible member on said elongated member toward a first
end of said elongated member of a character upon expansion to seal
the annulus between said elongated member and said body
passageway;
an inflatable member on said elongated member spaced longitudinally
from said expansible member toward the second end of said elongated
member to block said first passageway upon inflation, and palpable
to expel fluid contained in said inflatable member;
an inflatable chamber to receive said expelled fluid; and
differential flow control means interconnecting said inflatable
member and said inflatable chamber to enable said expelled fluid to
flow rapidly from said inflatable member to said inflatable chamber
and to enable fluid to flow more gradually from said inflatable
chamber into said inflatable member.
22. The indwelling valving device of claim 21 in which said
inflatable chamber is disposed within said first expansible
member.
23. The indwelling valving device of claim 21 in which said flow
control means comprises pressure relief means to enable said
expelled fluid to flow to said inflatable chamber and flow
restriction means to enable fluid to flow from said inflatable
chamber to said inflatable member.
24. The indwelling valving device of claim 21 in which said first
passageway includes a first section extending internally of said
elongated member from said first end to bypass said expansible
member and a second section comprising said annulus whereby said
second section bypasses said inflatable member upon said expulsion
of fluid from said inflatable member.
25. An indwelling valve assembly for controlling the flow of fluid
through a body passageway, comprising:
a valve comprising a sheath operative to expand from a collapsed
state to increase the flow area through the valve;
actuator means for selectively opening said valve; and
control means for delayed gradual closing of said valve,
said valve assembly operative to allow collapse of said sheath
while passing though areas of restricted diameter.
26. A valve assembly as in claim 25, further comprising a valve
member inflatable to close said valve.
27. A valve assembly as in claim 26, wherein said valve member
comprises a receptor for receiving fluid.
28. A valve assembly as in claim 27, further comprising:
a reservoir; and
a passageway extending from said valve member to said
reservoir.
29. A valve assembly as in claim 28 wherein said reservoir is
expandable to receive fluid from said valve member.
30. A valve assembly as in claim 28, wherein said control means is
responsive to said actuator means to allow fluid in said receptor
to flow to said reservoir and responsive to pressure on said
reservoir to yieldably resist flow of fluid from said reservoir to
said receptor.
31. A device for insertion into the urethra, comprising:
a fixation means for engagement with the bladder;
a valve for substantially preventing the flow of urine through the
urethra; and
an interconnecting member for interconnecting said fixation means
and said valve,
said valve including a sheath operative to collapse upon passage of
the device through areas of restricted diameter and expand upon
proper positioning in the urethra to increase the flow area through
said valve.
32. A urethral valving device, comprising:
a valve operable to collapse upon insertion into or withdrawal from
the urethra and expand while in a position within the urethra;
and
means for selectively opening said valve from a point external of
the body.
33. The device of claim 32, further comprising:
means for automatic delayed closing of said valve after said valve
has been opened.
34. The device of claim 32, further comprising:
a chamber vented to provide fluid communication between said
chamber and said valve and between said chamber and said urethra;
and
a plug operable in said chamber between a first position in which
said vents are open and a second position in which said vents are
closed.
35. An intraurethral valving device, comprising:
a flexible tubular body having distal and proximal ends and
defining a longitudinal passageway therethrough;
anchoring means for securing said body in place;
blocking means for blocking said passageway;
a valve chamber in said distal end of said body having vents to
provide fluid communication between said valve chamber and said
anchoring means, between said valve chamber and said blocking
means, and between said valve chamber and said urethra; and
a valve member operable in said valve chamber between a first
position in which said vents are all open and a second position in
which said vents are all closed.
Description
BACKGROUND OF THE INVENTION
The present invention relates generally to methods and apparatus
for valving bodily fluids, such as urine, and particularly to
urethral drainage catheters for controlling discharge of fluid from
the bladder and more and particularly to a device which is
completely implanted within the bladder and adjacent portions of
the urethra.
1. Field of the Invention
Urinary incontinence is a serious and long-recognized problem in
the medical field, and much effort has been directed to providing
devices for handling the problem. The number of patents granted in
this field are evidence of such efforts.
Urinary incontinence is the inability to voluntarily control the
elimination function of the bladder. This problem can result from
numerous causes, including old age, disease, trauma, or some form
of neurological dysfunction, and the problem is generally
incurable. The patient suffering from urinary incontinence may
experience embarrassment, discomfort, and loss of self-esteem. In
addition, normal human activity may be severely limited.
Attempts to alleviate this problem have generally involved either
external or external/internal devices. Examples of external devices
are adult diapers and urine alarms. External/internal devices such
as urinary catheters have also been studied. However, such
catheters have a limited indwelling life because of the likely
onset of serious urethral infections. The operation of such devices
is also severely complicated by the very limited diameter of the
urethra. These and other complications have made elusive the search
for an indwelling urine control device that achieves comfortable,
convenient and relatively "normal" bladder control for the
incontinent patient.
2. Description of the Related Art
Numerous devices have been developed to facilitate the controlled
discharge of the urinary bladder, one of the most common being a
urethral catheter extending from the bladder, through the entire
urethral tract, to the exterior of the body. The catheter is
ordinarily inserted into the bladder and retained in position by
inflatable cuffs or balloons. A drainage passageway extends the
length of the catheter, allowing urine to flow from the bladder to
the atmosphere. The drainage passageway may, alternatively, be
connected to a collector bag or include a shut-off valve for
controlling the passage of urine. U.S. Pat. Nos. 3,642,004
("Osthagen"), 3,811,450 ("Lord"), and 4,022,216 ("Stevens") are
representative of such devices.
The Osthagen, Lord, and Stevens devices have numerous well-known
disadvantages, not the least of which is susceptibility to
infection. The protruding catheter provides an ideal path for
migration of bacteria into the bladder, possibly resulting in
extreme complications. Further, the use of collector bags can be
both uncomfortable and embarrassing, adversely affecting the
wearer's psyche. Finally, use of devices which extend beyond the
urethra restricts or prohibits normal activities.
Another approach to the problem of controlling urinary incontinence
has been to provide a means for constricting the urethra to block
the flow of urine, with the capability of selectively releasing the
constriction to allow voiding of the bladder. Such devices are
described in U.S. Pat. Nos. 3,939,821 ("Roth") and 3,750.,194
("Summers"). The most common problems associated with the use of a
constricting device are impaired circulation, edema, and urethral
diverticulum.
Still other methods have been developed to control urinary
incontinence by using completely indwelling devices. U.S. Pat. Nos.
3,768,102 ("Kwan-Gett") and 3,797,478 ("Walsh") describe devices
which rely on normal voiding pressure being exerted by the wearer
to overcome a threshold resistance and start the flow of urine. The
devices automatically return to a closed state upon evacuation of
the bladder. Another such device is shown in application Ser. No.
6-550,040, filed by Stephen B. Leighton ("Leighton").
Other indwelling urethral catheters have incorporated valves which
are actuated by external forces. U.S. Pat. No. 3,812,841 to
Isaacson ("Isaacson") shows a urethral valve which is implanted in
the urethra at its point of entry into the bladder. Inflatable
collars hold the structure in place while a valve internal to the
device prevents the flow of urine through the drainage canal. The
valve is magnetic in nature and responds to a magnetic field
generated at the exterior of the body. The external field causes
the valve to open, thus allowing the bladder to be voided through
the urethra, and removal of the field then allows the valve to
return to a closed position. The numerous mechanical parts of the
Isaacson valve increase the possibility of malfunction of the unit
and consequential repair or replacement. Further, the physical size
and relative inability of the catheter to collapse, being of
"slightly flexible deformable plastic" and sufficiently large to
obstruct the urethra near the bladder, present extreme difficulties
in insertion and removal.
U.S. Pat. Nos. 4,350,161 and 4,432,757, both to Davis, Jr.
("Davis") show an indwelling urethral catheter used by males which
is secured in the bladder by a Foley-type balloon and which extends
the length of the urethra to the penile urethra. A valve is mounted
in the distal end of the catheter and is normally biased to a
closed position. The valve is actuable to an open position by
external hand manipulation of the penis. Although the Davis
catheter does not extend to the penile meatus, it occupies a
significant portion of the penile urethra. Such a position reduces
the length of urethra which is subject to the normal flushing of
urine and may invite migratory infections. Further, location of the
distal end of the catheter and the valve in the penile urethra may
result in considerable discomfort upon expansion and contraction of
the penis, as upon erection. Finally, as in Isaacson, the rigid
valve structure can be a source of considerable discomfort and
trauma both in insertion and removal and during normal usage.
One object of the present invention is to overcome many of the
above-mentioned drawbacks by providing a manually actuated urinary
continence device which is completely indwelling within the urinary
tract, thereby reducing the possibility of infection associated
with many of the prior devices.
SUMMARY OF THE INVENTION
According to the present invention, a method and apparatus for
valving bodily fluids may involve a device which is intended to be
located in the urethra between the bladder and the penile meatus.
The device does not extend outside the penis and thereby may
provide protection against infection. The device is secured in
place by means of inflatable balloons located generally in the
bladder and in the proximal urethra area, inhibiting significant
movement along the urethra in either direction.
A drainage passageway extends the length of the device and
facilitates evacuation of the bladder. The passageway is blocked by
a collapsible valve which is manually actuable to an open position.
Once opened, the valve remains open for a short period of time to
allow evacuation of the bladder and, after the delay, automatically
returns to its closed position.
The valve is collapsible from its normal shape to allow ease of
insertion through areas of restricted diameter in the urethra. When
properly positioned, the valve resumes its normal shape, increasing
its cross-sectional area and, thus, the flow area therethrough.
An insertion tool attaches to the device for insertion into the
patient's urethra, inflating the balloons which hold the device in
place, thereby inflating the collapsible valve. Inflation passages
in the insertion tool communicate with the device via self-sealing
valves, or septums. Following insertion of the device and inflation
of the balloons and collapsible valve, the insertion tool is
withdrawn from the urethra, leaving the device in place. The
self-sealing valves prevent deflation of the balloons and valve
upon withdrawal of the insertion tool.
The device is removable from the urethra generally by means of a
cystoscope or similar device. A plug at the distal end of the
device is grasped by the withdrawal tool and pulled, allowing
deflation of the balloons and collapsible valve and providing a
means for withdrawing the device from the urethra. Alternatively, a
monofilament cord, or similar device, may be attached to the plug
and allowed to extend outside the urethra to be grasped and pulled
to deflate the balloons and valve and facilitate removal of the
device.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates one preferred embodiment of the present
invention as it is positioned in the male urethra with the
insertion/inflation tool attached.
FIG. 2 is a view of the device of FIG. 1 as sectioned along its
longitudinal axis showing the balloons and valve in inflated
conditions with the insertion/inflation tool attached.
FIG. 3 is a cross-section of the device taken along lines 3--3 in
FIG. 2.
FIG. 4 is a cross-section of the device taken along lines 4--4 in
FIG. 2.
FIG. 5 is a cross-section of the device taken along lines 5--5 in
FIG. 2.
FIG. 6 is an enlarged, longitudinal section view of bleed-back
device 40 shown in FIG. 2.
FIG. 7 is a perspective view of one embodiment of an insertion tool
that may be used with the present invention.
FIG. 8 is a view of the device as sectioned along its longitudinal
axis showing the plug removed and the balloons and valve in
deflated conditions .
DETAILED DESCRIPTION
FIG. 1 illustrates one embodiment of a device 10 of the present
invention positioned within the male urethra 17. Inflatable
balloons 11 and 12, located within the bladder 13 and the proximal
urethra, respectively, anchor the device 10 in place and secure it
against significant movement in either direction. A valve assembly
15 is located below inflatable balloon 12 and, when inflated,
obstructs the urinary passage 21 (shown in FIG. 2) within the
device 10 to prevent the flow of urine from the bladder 13.
The location of the valve assembly 15 is variable, as is the
overall length of the device 10, and FIG. 1 illustrates only one
embodiment of the invention, that being the preferred embodiment.
In this embodiment, as noted above, inflatable balloons 11 and 12
are located in the bladder and proximal urethra and valve assembly
15 is located in the region of the bulbous urethra.
Referring now to FIG. 2, a preferred embodiment of device 10
generally comprises a tubular body 20 with a balloons 11 and 12
serve to anchor the device 10 within the bladder and urethra and
valve assembly 15 controls the flow of urine through passageway
21.
Tubular body 20 is preferably formed of a flexible material, for
example, silicone, to facilitate insertion and removal of the
device as well as to decrease the discomfort normally associated
with the use of such a device. The material should preferably be
biocompatible so as not to cause complications within the urinary
tract. The diameter of tubular body 20 is very restricted so that
it will easily pass through restricted regions of the urethra.
As noted above, tubular body 20 contains a passageway, or lumen, 21
extending longitudinally the length of device 10. A port 27,
located at proximal end 26 of device 10-, allows for the entry of
urine into passageway 21.
Located adjacent port 27 is inflatable balloon 11. The balloon 11
is formed from a resilient and stretchable material and comprises a
tube concentric about body 20 with a diameter approximating that of
body 20. The upper and lower ends of balloon 11 are affixed at
points X and Y to the exterior surface of body 20 by means of a
silicone adhesive, or similar means. The central portion of balloon
11 is thus expandable in response to internal pressurization to
form a circumferential barrier, or cuff, about tubular body 20.
Balloon-filling port 18 penetrates the side wall of body 20 and is
longitudinally situated between the upper and lower peripheries of
balloon 11, points X and Y. Within tubular body 20 and in
communication with port 18 is a second longitudinal passageway, or
lumen, 31, which will be more fully described below.
Spaced longitudinally from balloon 11 is fixation balloon 12.
Balloon 12 is formed in a manner similar to that of balloon 11 and
is affixed in like manner to the exterior of body 20 at points W
and Z, thus forming a second circumferential barrier, or cuff.
Balloon-filling port 19, as in the case of port 18, penetrates the
side wall of body 20 and is longitudinally situated between the
upper and lower peripheries of fixation balloon 12, points W and Z.
Contained within tubular body 20 and in communication with port 19
is a third longitudinal passageway 32, which will be more fully
explained below.
Near distal end 28 of device 10 is a collapsible valve assembly 15.
The assembly 15 generally comprises an inflatable bulb 34, ports
36, and flexible sheath 33. The sheath 33 is formed from a
semi-resilient material similar to that of body 20 and balloons 11
and 12 and is of a tubular construction. The sheath 33 fits over
the distal end 28 of tubular body 20, forming an annular space
therebetween, and its proximal end 42 is permanently affixed about
the circumference of body 20 using a silicone adhesive or similar
means.
Sheath 33 is pre-formed in a shape resembling an ellipse so that
its diameter at its central region is greater than its diameter at
either end. This is most easily seen in FIGS. 2 and 8. When in its
normal condition, the sheath 33 forms an annular space about the
body 20 which is typically larger in cross-sectional flow area than
the annular space defined when the sheath 33 is collapsed against
the body 20, as when passing through areas of restricted
diameter.
Contained within the annular space formed between body 20 and
sheath 33 is an inflatable bulb 34. The bulb 34 is formed in like
manner to balloons 11 and 12 and is affixed to the exterior of the
body 20 in a similar manner. The valve ports 36 penetrate the side
wall of tubular body 20 and provide fluid communication between the
interior of bulb 34 and valve control passage 35, which will be
more fully explained below.
FIG. 2 illustrates the locations and interconnections of passages
21, 31, 32, and 35. Longitudinal passageway 21 extends from port 27
at proximal end 26 of device-10, along the longitudinal axis of
body 20 to the proximal end 42 of sheath 33. The annulus formed
between the sheath 33 and tubular body 20 creates an extension of
urinary passageway 21 from the proximal end 42 of sheath 33 to the
distal end 28 of device 10. Balloon-filling passage 31 extends
along the longitudinal axis of body 20 from proximal end 26 to
distal end 28 of device 10. As explained above, passage 31 is
connected to the interior of inflatable balloon 11 by means of port
18. At its proximal end, passage 31 is connected to flow control
mechanism 38, the structure of which will be more fully explained
below. Balloon-filling passage 32 is also situated along the
longitudinal axis-of body 20 and extends from fixation balloon 12
to distal end 28. Again as explained above, the passage 32 is
connected to the interior of fixation balloon 12 by means of the
port 19. Valve control passage 35 is situated along the
longitudinal axis of body 20 and extends from proximal end 26 to
chamber 22 near the distal end 28. At its proximal end, passage 35
is connected to flow control mechanism 38. Ports 36 provide fluid
connection between passage 35 and the interior of inflatable bulb
34.
Inflatable bulb 34 in its inflated condition presses against sheath
33, as shown in FIGS. 2 and 3. The body 20 is substantially
oval-shaped in its cross-section and contains passages 31, 32, and
35. A port 36, illustrated in FIG. 3, connects valve control
passage 35 with the interior of inflatable bulb 34.
Referring to FIG. 4, the body 20 is generally circular in
cross-section in the area of fixation balloon 12 and contains the
semi-circular urinary passageway 21 and the pie-shaped
balloon-filling passages 31 and 32, and valve control passage 35.
The general shape and configuration of the various passages
provides for optimal use of the restricted diameter of body 20;
however, other shapes and arrangements may be used. It is preferred
that the diameter of body 20 be minimized for reasons which will be
more fully explained below. The port 19 connects the
balloon-filling passage 32 with the interior of fixation balloon
12.
The portion of body 20 near the balloon 11 contains urinary
passageway 21, balloon-filling passage 31, and valve control
passage 35, as shown in FIG. 5. Port 18 connects balloon-filling
passage 31 and the interior of inflatable balloon 11. The balloons
12 and 11 are concentric with the-circumference of body 20. FIG. 3
illustrates that both inflation bulb 34 and sheath 33 are
circumferential about body 20 and are concentric with one
another.
Flow control mechanism 38 is located within tubular body 20 at its
proximal end. The mechanism 38 comprises two primary elements. A
check valve 39 is connected at one end to balloon-filling passage
31 and at its other end to valve control passage 35. Check valve 39
allows one-way flow of fluid from passage 35 into passage 31 but
will not allow fluid to flow from passage 31 to passage 35.
Bleed-back device 40 is connected to passages 31 and 35 and is
connected in parallel to check valve 39. Bleed-back device 40, as
used in one embodiment, is illustrated in FIG. 6 as a screw 43
loosely threaded into port 44. Threads 46 in port 44 generally
provide a loose fit with threads 45 on screw 43, resulting in a
helical flow path from passage 31 to passage 35. The operation of
flow control mechanism 38 will be explained in detail below.
The chamber 22 is located at distal end 28 of device 10 and is
generally cylindrical in shape. The cylindrical chamber is formed
along the longitudinal axis of body 20 and extends from adjacent
inflatable bulb 34 to the distal end 47 of tubular body 20. At one
end, chamber 22 is open to the exterior of body 20 and, at its
other end, chamber 22 is connected to passages 31 and 32 by means
of vents 23 and 24, respectively. Passage 35 terminates, at its
distal end, in chamber 22. Chamber 22 is configured to accept a
generally cylindrical plug 25. Plug 25 fits within chamber 22 to
obstruct vents 23 and 24 and the distal end of passage 35. The plug
25 may be attached to body 20 by means of a suture 41 looped about
the circumference of body 20, as shown in FIG. 2.
Also located at distal end 28 of device 10 are self-sealing valves,
or septums, 29 and 30. As explained above, balloon-filling passages
31 and 32 extend along the longitudinal axis of body 20 to distal
end 47 of body 20. Self-sealing valves 29 and 30 may be formed from
any resilient substance which may be penetrated by a needle and
which will collapse upon itself upon withdrawal of the needle. In
the preferred embodiment, that substance is silicone. Valves 29 and
30 generally resemble silicone plugs located within the distal ends
of balloon-filling passages 31 and 32.
The operation of device 10 may be substantially as follows:
Prior to insertion into the urethra, device 10, representing a
preferred embodiment of the present invention, is in a completely
deflated state. Balloons 11 and 12 and bulb 34 are collapsed
against the exterior of body 20. Sheath 33 is in its normal shape,
bulged away from body 20. Plug 25 is inserted into chamber 22,
obstructing vents 23 and 24, and passageway 35, preventing flow of
fluid therebetween.
Insertion tool 50, illustrated in FIG. 7, is attached to the distal
end 28 of device 10. Needles 51 and 52 penetrate self-sealing
valves 29 and 30, and sleeve 55 on the distal end 28 of device 10
fits snugly around the proximal end 55 of insertion tool 50.
Insertion tool 50 is generally in the configuration of a Foley-type
catheter, with certain important modifications, and is made of a
flexible material such as that used in device 10. Although the
Foley-type catheter is generally known to those skilled in the art,
the tool 50 departs from construction of the typical Foley-type
catheter in certain important ways, particularly in the arrangement
of the proximal end 55.
After insertion tool 50 has been attached to device 10, the device
is guided into and along the urethra into its proper position.
Because of the small diameter of device 10 and the collapsible
nature of balloons 11 and 12 and valve assembly 15 (including
sheath 33 and bulb 34), the device is easily maneuverable through
relatively narrow areas commonly found in the urethra, especially
the urethral meatus. Sheath 33, being of a flexible material,
collapses from its normal shape to lay against body 20 and
substantially eliminate the trauma normally associated with
insertion of intraurethral devices.
Once it is properly positioned, device 10 is completely within the
urethra, while the insertion tool 50 protrudes therefrom. Proximal
end 26 of device 10 has protruded into the bladder. Valve assembly
15 and sheath 33, when the device 10 is properly positioned, are
located in a generally enlarged area of the urethra, and sheath 33
assumes its pre-formed, bulging shape, thus enlarging the annular
space formed between sheath 33 and body 20, resulting in an
enlarged flow area in valve assembly 15.
A syringe generally used with Foley-type catheters is attached to
the insertion tool at points 53 and inflation fluid is injected
through self-sealing valves 29 and 30. A radiopaque fluid is
preferred to facilitate post-insertion x-ray and viewing of the
device while in the body. For example, Hypaque-25 or Renografin-60,
aqueous dilutions thereof, or equivalents, may be used as the
radiopaque fluid. Alternatively, a relatively compressible fluid
may be employed in an alternate embodiment.
After the device 10 has been properly positioned within the urethra
with its proximal end 26 protruding into the bladder, inflation
fluid is injected through self-sealing valve 29, along passageway
31, and into balloon 11, located within the bladder. As balloon 11
is inflated, a differential pressure begins to develop across flow
control mechanism 38. Check valve 39 is oriented so as to prevent
the flow of fluid from passage 31 into passage 35; however,
bleed-back device 40 will allow a gradual helical flow of fluid
along threads 45 and 46 from one passage to the other. As a result
of the pressure differential across mechanism 38, inflation fluid
begins to gradually flow through bleed-back device 40 and into and
through valve control passage 35. Fluid continues to flow through
ports 36, filling bulb 34 and causing it to begin to expand against
sheath 33. Because plug 25 is positioned within chamber 22,
obstructing the distal end of passageway 35, fluid cannot escape
from valve assembly 15. Sufficient fluid is injected through
self-sealing valve 29 and into passage 31 such that, when fluid
pressure is equalized between balloon 11 and bulb 34 and flow
through bleed-back device 40 ceases, balloon 11 is inflated to
secure device 10 within the bladder and bulb 34 is pressed against
sheath 33, blocking passage 21.
Because sheath 33 is resistively expandable, it will begin to
expand as bulb 34 expands under pressure from the inflation fluid.
However, the sheath 33 offers resistance to or bias against
continued expansion of bulb 34, creating an effective seal within
the annular space between bulb 34 and sheath 33. By varying the
volume of inflation fluid injected through self-sealing valve 29,
the effectiveness of the seal between sheath 33 and bulb 34 can be
varied.
Because the valve 15 operates by radial expansion, a relatively
large area of sealing contact between sheath 33 and bulb 34 may be
achieved. This large contact area improves the sealing efficiency
of the valve 15.
When the predetermined volume of fluid has been injected into
balloon 11, a slight pull on the insertion tool serves to seat the
device at the bladder neck. This anchoring prevents migration of
the device from the bladder. The syringe is then used to inject
inflation fluid through self-sealing valve 30, along passage 32,
through port 19, and into balloon 12. Sufficient fluid is injected
to adequately secure the device 10 in its proper position.
Additionally, balloon 12 serves to seal the annular region formed
between the tubular body 20 of device 10 and the urethra, thereby
helping to prevent leakage of urine along the exterior wall of
device 10.
When the device 10 has been properly inflated, the insertion tool
is disconnected from the device with a steady pull and is withdrawn
from the urethra. As the insertion tool is disconnected from device
10, needles 51 are withdrawn from self-sealing valves 29 and 30 and
their self-sealing nature seals the holes created by penetration of
the needles. The inflation fluid is thus prevented from escape from
device 10.
The seal created between sheath 33 and bulb 34 obstructs
longitudinal passageway 21 and prevents the flow of urine from the
bladder through the passageway. However, in the event bladder
pressure exceeds the inflation fluid pressure at the seal, "leak
through" can occur. Indeed, such a capability may be desired in
order to signal the need for voiding the bladder. If "leak through"
is not desired, pressure at the seal may be increased by injection
of a greater volume of inflation fluid. Again, the point at which
"leak through" will be allowed can be controlled by the volume of
inflation fluid injected.
When voiding of the bladder is desired, device 10 is operated as
follows:
Valve assembly 15 is palpated by manually pressing a point external
of the body in the area of the assembly. In the preferred
embodiment, valve assembly 15 is located near the perineum, as
shown in FIG. 1, and upwardly directed manual pressure on the
perineum is transmitted via the urethral wall to sheath 33 and bulb
34. Inflation fluid is pumped from bulb 34 through ports 36 and
valve control passage 35. Fluid readily flows through check valve
39 and into passage 31.
Because vent 23 is obstructed by plug 25, the fluid is forced into
balloon 11, causing it to expand. Balloon 11, therefore, functions
as a temporary reservoir for the fluid pumped from bulb 34. As bulb
34 becomes collapsed or deflated, the seal between it and sheath 33
is eliminated, opening the longitudinal passageway 21 and allowing
urine to flow from the bladder through the device to the exterior
of the body. In addition, because bulb 34 has been deflated and
balloon 11 is expanded with filling fluid, a pressure differential
is created across bleed-back device 40, causing a gradual flow of
fluid to return to bulb 34.
In another embodiment, using a compressible inflation fluid,
reservoir 11 may not expand beyond its normal anchoring size, but
rather may compress the inflation fluid as it is received. The
reduced fluid pressure in bulb 34 will allow it to collapse as
above and the increased pressure in reservoir 11, created by the
compression of the fluid, will effectuate the differential pressure
necessary to cause the gradual flow of fluid from reservoir 11 to
bulb 34.
Returning to the illustrated embodiment, this gradual flow
continues until the pressure between balloon 11 and bulb 34 is once
again equalized. The return of fluid from balloon 11 to bulb 34
through bleed-back device 40 is gradual enough so as to allow ample
time for the bladder to void. During normal operation of device 10,
fixation balloon 12 is unaffected and maintains its anchoring
effect and seal against the urethral wall.
When device 10 is to be removed from the urethra, a cystoscope, or
similar tool, is used to pull the plug 25 from its position within
chamber 22, as indicated in FIG. 8. Balloons 11 and 12 are emptied
through passages 31 and 32, vents 23 and 24 and chamber 22. In
addition, inflation fluid contained in bulb 34 is allowed to escape
through ports 36, valve control passage 35, and chamber 22.
Balloons 11 and 12 and bulb 34 become collapsed and valve assembly
15 becomes readily collapsible, facilitating removal of the device
from the urethra. The plug 25 is connected to device 10 by means of
a suture 41, or similar connection, and removal of the device from
the urethra is accomplished by gripping and pulling on the plug 25
with a cystoscope or similar tool. As was the case on insertion,
the collapsible nature of valve assembly 15 and the restricted
diameter of tubular body 20 allow the passing of the device through
various restricted areas along the urethra.
Although the above description describes details of a preferred
embodiment of the present invention, it will be understood by those
skilled in the art that numerous other embodiments and applications
of the invention exist. Although in many such applications, all of
the advantages of the illustrated embodiment may not be achieved,
certain desirable attributes may be attainable. For-example, the
length of the device may be varied for specific applications and
the device need not be restricted to use in the male urethra, or
even to use in humans. Further, the sheath 33 may be omitted in
certain situations, in which case inflatable bulb 34 seals against
the wall of the urethra with the urinary passageway 21 terminating
above inflatable bulb 34. Still further, use of the invention will
not require two balloons in certain applications; for example,
where migration must be prevented in only one direction or where
one inflatable balloon will prevent movement in more than one
direction. Indeed, inflatable circumferential balloons 11 and 12
may each be replaced with one or more inflatable balloons situated
about the circumference of the catheter body. Flow control
mechanism 38 may assume numerous configurations which achieve
immediate flow of fluid in one direction and delayed or gradual
flow of fluid in the opposite direction.
The collapsible valve of the invention will find use not only in
embodiments such as the urethral device described herein but also
in any indwelling situation where a collapsible, expandable valve
is desired to control the flow of body fluids. Such situations
could include catheters for use in blood vessels as well as devices
for controllably blocking other body passages, e.g., esophagus or
colon.
In the embodiment described herein, the collapsible valve is small
enough to pass through restricted areas of the urethra,
particularly the penile meatus, without significant trauma, and
yet, when it is properly positioned in the bulbous urethra, it may
be expanded to a size which is easily palpable but much too large a
diameter to ever pass through such restricted areas. Likewise, in
other embodiments and applications, the collapsible and expandable
nature of the valve provides easy passage and positioning as well
as expansion to an effective functioning size once positioned. The
actual mechanism for operation of the valve once in position is
relatively unimportant as long as the collapsing and expanding
features of the valve structure, as a whole, are not compromised.
For example, other means for collapsing, expanding, opening or
closing the valve during normal use could utilize magnetic
actuators, mechanical actuators, contracting and expanding fluids,
compressible fluids, or other effective devices.
It is to be understood that the invention is to be limited only by
the appended claims.
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